Pitolisant to Assess Weekly Frequency of Cataplexy Attacks and EDS in Narcoleptic Patients (HARMONY CTP)

Conditions

Excessive Daytime Sleepiness, Narcolepsy With Cataplexy

Keywords

Narcolepsy, Cataplexy, Sleep disorder, Excessive daytime sleepiness

Brief summary

Double blind, randomized, parallel groups study of Pitolisant versus placebo, in narcoleptic patients experiencing EDS, and cataplexy (minimum of 3 complete or partial cataplexy attacks per week). The patients will be treated during 7 weeks with Pitolisant or placebo.

Detailed description

The treatment period (7 weeks double blind) will aim at demonstrating the efficacy of Pitolisant on the number of cataplexy attacks and the Excessive Daytime Sleepiness by verifying whether the results of Pitolisant are superior to those of placebo. The safety will also be assessed.

Gerard Meskill, Craig W. Davis, Donna Zarycranski, Nicolai M. Doliba, Jean‐Charles Schwartz et al. (6 authors)

CNS Drugs2021-12-2113 citations

10.1007/s40263-021-00886-x

Time to Onset of Response to Pitolisant for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Patients With Narcolepsy: An Analysis of Randomized, Placebo-Controlled Trials.

Watson NF, Davis CW, Zarycranski D, Vaughn B, Dayno JM, Dauvilliers Y, Schwartz JC.

2021-11-254 citations

10.1007/s40263-021-00866-1

Safety and efficacy of pitolisant on cataplexy in patients with narcolepsy: a randomised, double-blind, placebo-controlled trial.

Szakacs Z, Dauvilliers Y, Mikhaylov V, Poverennova I, Krylov S, Jankovic S, Sonka K, Lehert P, Lecomte I, Lecomte JM, Schwartz JC, HARMONY-CTP study group.

2017-01-25118 citations

10.1016/s1474-4422(16)30333-7

Interventions

DRUGPitolisant

1 capsule in the morning before breakfast

DRUGPlacebo

1 capsule in the morning before breakfast

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

Main Inclusion Criteria: * Narcoleptic with cataplexy : at least 3 weekly cataplexy attacks * ESS \> or = 12 * ICF signed and dated Main

Exclusion criteria

* Other conditions that could generate EDS * Psychological and neurological disorders * Acute or chronic severe disease * Treatment by prohibited medication

Design outcomes

Primary

Measure	Time frame	Description
Measure of anticataplectic efficacy	At week 7	Measure of anticataplectic efficacy assessed by the change in the average number of cataplexy attacks per week.

Secondary

Measure	Time frame	Description
Excessive Daytime Sleepiness assessment	At week 7	Excessive Daytime Sleepiness assessment by evaluation of ESS score, and other questionnaires.
Safety assessment	11 weeks	Safety assessment thanks to AE recording, vitals signs assessment, ECG...

Countries

Hungary

Outcome results

None listed